A Phase 3 Study Evaluating Safety and Effectiveness of Immune Globulin Intravenous (IGIV 10%) for the Treatment of Mild-to-Moderate Alzheimer´s Disease

This study has been completed.
Sponsor:
Collaborator:
Alzheimer's Disease Cooperative Study (ADCS)
Information provided by (Responsible Party):
Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:
NCT00818662
First received: January 7, 2009
Last updated: March 18, 2013
Last verified: March 2013
  Purpose

The purpose of this study is to determine whether IGIV, 10% treatment, administered at two different doses for 18 months, slows the rate or prevents the progression of dementia symptoms in subjects with mild to moderate Alzheimer´s Disease (AD). Subjects will be randomly assigned to receive intravenous infusions of either of two doses of IGIV, 10% or placebo every two weeks for 70 weeks (36 infusions) as an add-on to conventional Food and Drug Administration (FDA)-approved AD medications.


Condition Intervention Phase
Alzheimer´s Disease
Drug: Immune Globulin Intravenous (Human), 10% (IGIV, 10%)
Other: Placebo solution
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Two Dose Arm, Parallel Study of the Safety and Effectiveness of Immune Globulin Intravenous (Human), 10% (IGIV, 10%) for the Treatment of Mild-to-Moderate Alzheimer´s Disease

Resource links provided by NLM:


Further study details as provided by Baxter Healthcare Corporation:

Primary Outcome Measures:
  • Cognition and global function [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Measured by the cognitive subscale of the Alzheime´s Disease Assessment Scale (ADAS-Cog) and the Alzheimer´s Disease Cooperative Study (ADCS)-Activities of Daily Living (ADL)


Secondary Outcome Measures:
  • Cognition and global function [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    Measured by ADAS-Cog and ADCS-ADL


Enrollment: 390
Study Start Date: December 2008
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1
Immune Globulin Intravenous (Human), 10% (IGIV, 10%)
Drug: Immune Globulin Intravenous (Human), 10% (IGIV, 10%)
400 mg/kg bodyweight every 2 weeks for 70 weeks
Other Name: Gammagard Liquid
Experimental: Group 2
Immune Globulin Intravenous (Human), 10% (IGIV, 10%)
Drug: Immune Globulin Intravenous (Human), 10% (IGIV, 10%)
200 mg/kg bodyweight every 2 weeks for 70 weeks
Other Name: Gammagard Liquid
Placebo Comparator: Group 3 Other: Placebo solution
4 or 2 mL/kg bodyweight every 2 weeks for 70 weeks

Detailed Description:

Study visits: Each subject will be tested at the investigational site, and if qualified, will be treated intravenously (through a vein) every two weeks for 70 weeks (approximately 18 months). The first three infusions must be done at the site, but if the infusions are well tolerated, subsequent infusions may be done by a qualified healthcare provider in the home or other suitable location. Each subject must return to the site every 3 months for evaluation of cognition as well as blood tests and scans of the brain.

  Eligibility

Ages Eligible for Study:   50 Years to 89 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Written informed consent - subject (or subject´s legally acceptable representative) and caregiver who are willing and able to participate for the duration of the study
  • Diagnosis of probable Alzheimer´s Disease (AD)
  • Dementia of mild to moderate severity defined as mini-mental state examination (MMSE) 16-26 inclusive at the time of screening
  • Neuroimaging (computed tomography [CT] or MRI) performed after symptom onset consistent with AD diagnosis
  • Ability to comply with testing and infusion regimen, including fluency in English or Spanish, adequate corrected visual acuity and hearing ability
  • On stable doses of FDA approved AD medication(s) for at least 3 months prior to screening. These medications must be continued throughout this study.
  • If receiving psychoactive medications (e.g. antidepressants other than monoamine oxidase inhibitors (MAOIs) and most tricyclics, antipsychotics, anxiolytics, anticonvulsants, mood stabilizers, etc), must be on stable doses for at least 6 weeks prior to screening

Exclusion Criteria (Reasons why it might not be appropriate to participate):

  • Any other forms of dementia
  • Medical issues that might increase the risk of treatment with IGIV, 10%, such as:

    1. Significant problems with blood pressure, heart disease, clotting disorders, strokes or recent heart attacks
    2. Evidence of current bleeding in the brain by MRI
    3. Serious problems with the liver or kidneys
    4. Allergies to blood products
  • Medical issues that might interfere with the evaluation of the treatment of dementia or might make dementia worse, such as:

    1. Diabetes
    2. Recent treatment with chemotherapy or immune suppression
    3. The recent use of other investigational drugs, especially antibody therapy for AD
    4. Severe headaches or psychiatric problems

There are other reasons why it might not be appropriate to participate in this trial. Please consult an investigator at one of the trial sites for details.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00818662

  Hide Study Locations
Locations
United States, Alabama
University of Alabama, Birmingham
Birmingham, Alabama, United States, 35294
United States, Arizona
Banner Alzheimer´s Institute
Phoenix, Arizona, United States, 85006
Banner Sun Health Research Institute
Sun City, Arizona, United States, 85351
University of Arizona
Tucson, Arizona, United States, 85724
United States, California
University of California
Irvine, California, United States, 92697
University of California, San Diego, Department of Neurosciences
La Jolla, California, United States, 92093
University of Southern California
Los Angeles, California, United States, 90033
Synergy Clinical Research Center
National City, California, United States, 91950
University of California, Irvine
Orange, California, United States, 92868
United States, Connecticut
Yale University School of Medicine
New Haven, Connecticut, United States, 06510
United States, District of Columbia
Howard University
Washington, District of Columbia, United States, 20060
Georgetown University
Washington, District of Columbia, United States, 20057
United States, Florida
Wien Center for Clinical Research
Miami Beach, Florida, United States, 33140
Roskamp Institute
Sarasota, Florida, United States, 34243
University of South Florida / Suncoast
Tampa, Florida, United States, 33613
United States, Iowa
University of Iowa
Iowa City, Iowa, United States, 52242
United States, Kansas
University of Kansas
Kansas City, Kansas, United States, 66160
United States, Kentucky
University of Kentucky
Lexington, Kentucky, United States, 40536
United States, Massachusetts
Lahey Clinic, Inc.
Burlington, Massachusetts, United States, 01805
United States, Michigan
Bronson Lake View Psychiatry
Paw Paw, Michigan, United States, 49079
United States, Minnesota
Mayo Clinic, Rochester
Rochester, Minnesota, United States, 55905
United States, Missouri
St. Louis University
St. Louis, Missouri, United States, 63104
United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198-5580
United States, Nevada
Cleveland Clinic Lou Ruvo Center for Brain Health
Las Vegas, Nevada, United States, 89106
United States, New York
Neurological Care of CNY
Liverpool, New York, United States, 13088
Columbia University
New York, New York, United States, 10032
The Weill Cornell Memory Disorders Program (Cornell University)
New York, New York, United States, 10021
New York University Medical Center
New York, New York, United States, 10016
Mount Sinai School of Medicine
New York, New York, United States, 10029
University of Rochester Medical Center
Rochester, New York, United States, 14620
United States, Ohio
University Hospitals Case Medical Center
Beachwood, Ohio, United States, 44122
United States, Oklahoma
Tulsa Clinical Research
Tulsa, Oklahoma, United States, 74104
United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States, 97201
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
United States, South Carolina
Medical University of South Carolina
N. Charleston, South Carolina, United States, 29406-6076
United States, Tennessee
Psychiatric Consultants
Franklin, Tennessee, United States, 37067
United States, Texas
University of Texas, Southwestern Medical Center
Dallas, Texas, United States, 75390-9070
United States, Utah
University of Utah Center for Alzheimer´s Care, Imaging and Research
Salt Lake City, Utah, United States, 84108
United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53705
Canada, British Columbia
University of British Columbia
Vancouver, British Columbia, Canada, V6T 2B5
Canada, Ontario
Parkwood Hospital
London, Ontario, Canada, N6C 5J1
Toronto Memory Program
Toronto, Ontario, Canada, M3B 2S7
Canada, Quebec
Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2
Sponsors and Collaborators
Baxter Healthcare Corporation
Alzheimer's Disease Cooperative Study (ADCS)
Investigators
Study Director: Norman Relkin, MD, PhD Alzheimer's Disease Cooperative Study (ADCS)
Study Director: David Gelmont, MD Baxter Healthcare Corporation
  More Information

No publications provided

Responsible Party: Baxter Healthcare Corporation
ClinicalTrials.gov Identifier: NCT00818662     History of Changes
Other Study ID Numbers: 160701
Study First Received: January 7, 2009
Last Updated: March 18, 2013
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by Baxter Healthcare Corporation:
Alzheimer´s
Dementia
Dementia of Alzheimer Type
Immunoglobulins
Gammaglobulins
IVIG
Antibodies
Amyloid
Immunotherapy

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Antibodies
Immunoglobulins
Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 31, 2014